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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-01-17 to 2012-01-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EU Guideline Testing of Chemicals B46
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD guideline 429
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sponsor's identification: Ethyl-3-methyl-3-phenyloxirane-2-carboxylate
Description: Clear colourless liquid
Batch number: AS00075464
Purity: Not supplied
Date received: 2011-10-03
Expiry date: 2013-05-10
Storage conditions:Room temperature in the dark

Test animals

Species:
other: reconstituted human epidermis model
Strain:
other: reconstituted human epidermis model
Details on test animals and environmental conditions:
Not applicable

Test system

Type of coverage:
other: topical
Controls:
not required
Amount / concentration applied:
TEST ITEM

The test item was applied neat.

Amount(s) applied (volume or weight with unit):
Approximately 10 µL of the test item was applied to the epidermis surface.

Concentration (if solution):
The test item was used as supplied.

VEHICLE
No vehicle used
Duration of treatment / exposure:
15 minutes & 42 hour post exposure incubation
Observation period:
Not applicable
Details on study design:
TEST SITE
Area of exposure:
Approximately 10 µL of the test material was applied to the epidermis surface.

% coverage:
The test item was applied topically to the corresponding tissues ensuring uniform covering.

At the end of the exposure period, each tissue was removed from the well using forceps and rinsed using a wash bottle containing PBS with Ca²⁺ and Mg²⁺. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test material.

Time after start of exposure:
15 Minutes post exposure

SCORING SYSTEM
Quantitative MTT Assessment (percentage tissue viability):
For the test material the relative mean tissue viabilities obtained after the 15 minute treatment followed by the 42 hour post-exposure incubation period were compared to the mean of the negative control treated tissues (n=3). The relative mean viabilities were calculated in the following way:

mean OD₅₄₀ of test material / mean OD₅₄₀ of negative control x 100 = Relative mean tissue viability (percentage of negative control)

Classification of irritation potential is based upon relative tissue viability following the 15 minute exposure period followed by the 42 hour post-exposure incubation period according to the following:

Mean tissue viability is ≤ 50 %: Irritant (Xi) R38

Mean tissue viability is >50% : Non-Irritant

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: Viability of cells
Remarks on result:
other:
Remarks:
Basis: mean Viability of cells. Time point: day 6. Reversibility: other: not applicable. Remarks: See "Viability of cells" below. (migrated information)

In vivo

Other effects:
No

Any other information on results incl. tables

References

1) Fentem, J.H., Briggs, D., Chesne, C., Elliott, G.R., Harbell, J.W., Heylings, J.R., Portes, P., van de Sandt, J.J.M. and P.A. Botham (2001) A prevalidation study on in vitro tests for acute Skin Irritation: results and evaluation by the Management Team. Toxicology in vitro 15, pp.57-93.

2) Zuang, V., Balls, M., Botham, P.A., Coquette, A., Corsini, E., Curren, R.D., Elliot, G.R., Fentem, J.H., Heylings, J.R., Liebsch, M., Medina, J.,Roguet, R., van de Sandt, J.J.M., Wiemann, C. and A.P Worth (2002). Follow-up to the ECVAM prevalidation study on in vitro tests for acute Skin Irritation. ECVAM Skin Irritation Task Force Report 2. ATLA30, pp. 109-129.

3) Cotovio, J., Grandidier, M-H., Portes, P., Roguet, R. and G. Rubinsteen (2005) The in vitro acute Skin Irritation of chemicals: Optimisation of the EPISKIN Prediction Model within the Framework of the ECVAM Validation Process. ATLA33, pp.329-349.

4) Hartung. T. (2007) ESAC statement on the validity of in vitro tests for skin irritation. European Commission, Directorate General, Joint Research Centre, Institute for Health and Consumer Protection, European Centre for the Validation of Alternative Methods (ECVAM). Ispra. Website: http://ecvam.jrc.it/index.htm.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test item was considered to be Non-Irritant (NI) when tested in an in vitro EPISKIN™ reconstructed epidermis model.